Evaluation of a New EUS Guided Biopsy Needle (SharkCore) Comparing to Standard EUS Needle (ProCore)

Johns Hopkins University

Status and phase: Withdrawn; Phase 2

Conditions: Autoimmune Pancreatitis; Mesenchymal Tumor; Lymphoma; Solid Tumors

Treatments: Procedure: EUS-FNB with ProCore needle; Procedure: EUS-FNB with SharkCore needle; Device: SharkCore needle; Device: ProCore needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02766842

IRB00095614

Details and patient eligibility

About

Diagnosis of lesions of pancreas, the upper gastrointestinal tract, as well as adjacent structures, such as lymph nodes, is still showing advancements especially with the increased use of endoscopic ultrasound. Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for these lesions. The purpose of the study is to compare between the currently used, ProCore needles and the new biopsy needle, SharkCore, for the histological diagnosis and evaluation of lesions.

Full description

Endoscopic ultrasound-guided fine needle aspiration and fine needle biopsy (EUS-FNA/FNB) have become mainstay diagnostic techniques for the diagnosis and evaluation of lesions of the pancreas, the upper gastrointestinal tract, as well as adjacent structures, including lymph nodes. Cytology specimens provided from FNA cannot fully characterize certain neoplasms such as lymphomas or mesenchymal tumors. Core biopsy specimens for histological examinations are needed to provide accurate diagnoses.

ProCore needles (ProCore, Wilson-Cook Medical Inc. Winston-Salem, NC) were designed to obtain histological and cytological samples. Studies comparing ProCore needles with standard FNA needles showed no significant difference in diagnostic accuracy, histological core tissue procurement or mean number of passes.

To overcome the above mentioned limitations (mainly suboptimal core tissue procurement rates), a new novel SharkCore needle (Beacon Endoscopic, Newton, MA, USA) has been designed and approved for clinical human use by the FDA.

The objective of the study is to compare the new EUS guided histology biopsy needle SharkCore to the currently used EUS histology needle, ProCore, for the histological diagnosis and evaluation of lesions.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients ≥ 18 years of age referred for EUS

Lesions requiring histologic diagnosis:

• Mesenchymal tumors
• Autoimmune pancreatitis
• Granulomatous disease
• Indeterminate hepatitis
• Confirmatory immunochemistry to establish a diagnosis (i.e. pancreatic neuroendocrine tumor)
• Lymphoma
• Solid tumors
• Previously non-diagnostic FNA

Exclusion criteria

• Uncorrectable coagulopathy (INR > 1.5)
• Uncorrectable thrombocytopenia (platelet < 50,000)
• Uncooperative patients
• Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
• Refusal to consent form
• Cystic lesions
• Inaccessible lesions to EUS (proximal to sigmoid colon or distal to second duodenum)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

EUS-FNB with ProCore needle

Active Comparator group

Description:

General anesthesia or conscious sedation will be started and an upper endoscopic ultrasound will be inserted into the participants mouth and advanced to the site of the lesion. The lesion will be punctured by the ProCore needle, then the stylet is completely removed, and negative suction pressure is applied using a 10 ml syringe for 30 seconds while the needle is stationary with the target. Then, the needle is moved back and forth several times within the target, utilizing the fanning technique. Finally, suction is released by closing the lock of the syringe and the needle is removed.

Treatment:

Procedure: EUS-FNB with ProCore needle

Device: ProCore needle

EUS-FNB with SharkCore needle

Active Comparator group

Description:

The procedure will be done in the same manner with same endoscopic technique and method of tissue procurement. The only difference will be using the SharkCore needle to acquire tissue.

Treatment:

Procedure: EUS-FNB with SharkCore needle

Device: SharkCore needle